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FDA 510(k) Application Details - K201504
Device Classification Name
Vinyl Patient Examination Glove
More FDA Info for this Device
510(K) Number
K201504
Device Name
Vinyl Patient Examination Glove
Applicant
Anhui Bytech Medical Supplies Co., Ltd.
LingBi Economic Development Zone(North)
SuZhou 234200 CN
Other 510(k) Applications for this Company
Contact
Cheng Wang
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LYZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/05/2020
Decision Date
05/10/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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